Friday, December 28, 2007

Central Drug Authority to be set up shortly : Ramadoss
Ghaziabad: A Central Drug Authority (CDA) will be set up soon to tackle spurious drug trade in the country.
Speaking at a function to release the fifth edition of Indian Pharmacopoeia here on Tuesday Union Minister for Health and Family Welfare Anbumani Ramadoss said, "A Central Drug Authority will be set up in the country very shortly to keep a check on the trade of fake and spurious medicine in the Indian market."
A law would also be enacted soon to tighten the noose on people involved in spurious drug trade, he said.
Ramadoss also inaugurated buildings of Homoeopathic Pharmacopoeia Laboratory for the promotion of homoeopathy and other forms of natural medication in our country.
PTI/Hindu, India - Dec 28, 2007
To read the news in full |
PermaLink Speaking at a function to release the fifth edition of Indian Pharmacopoeia here on Tuesday Union Minister for Health and Family Welfare Anbumani Ramadoss said, "A Central Drug Authority will be set up in the country very shortly to keep a check on the trade of fake and spurious medicine in the Indian market."
A law would also be enacted soon to tighten the noose on people involved in spurious drug trade, he said.
Ramadoss also inaugurated buildings of Homoeopathic Pharmacopoeia Laboratory for the promotion of homoeopathy and other forms of natural medication in our country.
PTI/Hindu, India - Dec 28, 2007
Labels: India
Wednesday, December 26, 2007

Clinical studies can be conducted with ease in India
India is a land of diversity where alternative systems of medicine like ayurveda, unani, siddha, and homeopathy are practiced with equal fervour as allopathy. Thus, clinical studies for their evaluation can also be conducted with ease. Internationally, there has been recognition of the Indian advantage, which is luring pharmaceutical companies to adopt collaborative outsourcing strategies so as to tap the potential to its fullest. Owing to these factors, India is globally attracting collaborative contract proposals for conducting clinical trials and many have already come forward to set up their clinical research organisations (CRO's).
Irrespective of the fact that a drug has been developed in India or abroad, or whether its clinical studies have already been conducted abroad, every new drug needs evidence from clinical research to support its launch. Thus, whether it is a new chemical entity or an existing drug that is being marketed for a new indication, clinical studies have to be conducted. Similarly, launch of new formulations, drug delivery systems or even new fixed dose combinations, require clinical data before they can be marketed. Hence, it is obvious that the area of clinical research holds immense scope and promise, for without the supporting data, drug launches are not feasible. Clinical research should not be merely viewed as a subsidiary to pre-clinical research. On the contrary, it is of prime importance, for it has to be conducted even in cases where pre-clinical studies are not warranted (new formulations/fixed dose combinations/bio-equivalence).
Clinical research holds tremendous scope and opportunities not only for trained medical, pharmaceutical and paramedical professionals, but also for regulatory authorities, government and the society at large. A mechanism of knowledge transfer can be worked out, which would lead to a definite improvement in hospital infrastructure. It will make available the state-of-the-art therapy for many deserving Indian patients who were hitherto deprived of such therapeutic advances. Consequently, the projected figures for the various aspects of clinical research (market value, revenue, staff requirement) for the next five years, promise a growth at a rate greater than 20 percent (Table 1).
Dr S K Gupta, Galpalli Niranjan D/Express Pharma, India - 26 Dec 2007
To read the news in full |
PermaLink Irrespective of the fact that a drug has been developed in India or abroad, or whether its clinical studies have already been conducted abroad, every new drug needs evidence from clinical research to support its launch. Thus, whether it is a new chemical entity or an existing drug that is being marketed for a new indication, clinical studies have to be conducted. Similarly, launch of new formulations, drug delivery systems or even new fixed dose combinations, require clinical data before they can be marketed. Hence, it is obvious that the area of clinical research holds immense scope and promise, for without the supporting data, drug launches are not feasible. Clinical research should not be merely viewed as a subsidiary to pre-clinical research. On the contrary, it is of prime importance, for it has to be conducted even in cases where pre-clinical studies are not warranted (new formulations/fixed dose combinations/bio-equivalence).
Clinical research holds tremendous scope and opportunities not only for trained medical, pharmaceutical and paramedical professionals, but also for regulatory authorities, government and the society at large. A mechanism of knowledge transfer can be worked out, which would lead to a definite improvement in hospital infrastructure. It will make available the state-of-the-art therapy for many deserving Indian patients who were hitherto deprived of such therapeutic advances. Consequently, the projected figures for the various aspects of clinical research (market value, revenue, staff requirement) for the next five years, promise a growth at a rate greater than 20 percent (Table 1).
Dr S K Gupta, Galpalli Niranjan D/Express Pharma, India - 26 Dec 2007
Labels: India
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